What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2026-02-26 compared with 2025-03-03 · 108 added, 100 removed, 478 unchanged (30% of the section changed)

13 unchanged sentences

We have audited the accompanying balance sheets of Edgewise Therapeutics, Inc.

(the Company) as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively, the financial statements).

(the Company) as of December 31, 2025 and 2024, the related statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2025, and the related notes (collectively, the financial statements).

We also have audited the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with U.S.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2025, in conformity with U.S.

generally accepted accounting principles.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025 based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Basis for Opinion

Basis for Opinions

The Company’s management is responsible for these financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Report on Internal Control Over Financial Reporting.

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(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the

financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

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Denver, Colorado

March 3, 2025

February 26, 2026

EDGEWISE THERAPEUTICS, INC.

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Balance as of December 31, 2024

Issuance of common stock, net of offering costs

Exercise of stock options and vesting of restricted stock units

Purchase of common stock under employee stock purchase plan

Stock-based compensation

Other comprehensive income

Balance as of December 31, 2025

The accompanying notes are an integral part of these financial statements.

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Cash flows from financing activities

Proceeds from issuance of common stock, net of underwriting discounts and commissions and offering costs

Proceeds from issuance of common stock, net of offering costs

Exercise of stock options

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NOTES TO FINANCIAL STATEMENTS

December 31, 2024 and 2023

NOTE 1 DESCRIPTION OF BUSINESS

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Edgewise Therapeutics, Inc.

(the Company) was incorporated as a Delaware corporation in May 2017, and it is headquartered in Boulder, Colorado.

The Company is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe muscle diseases for which there is significant unmet medical need.

(the Company) was incorporated as a Delaware corporation in May 2017, and is headquartered in Boulder, Colorado.

The Company is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe muscle diseases for which there is significant unmet medical need.

The Company’s lead product candidates are sevasemten and EDG-7500:

Sevasemten is an orally administered small molecule designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (Duchenne) and Becker muscular dystrophy (Becker).

The Company is currently studying sevasemten in Phase 2 trials, which are being held in the U.S.

and Israel and in certain countries in Europe and Australasia.

The Company is enrolling a multipart Phase 2 trial with EDG-7500, for the potential treatment of hypertrophic cardiomyopathy (HCM).

The Company is using its proprietary drug discovery platform to develop a pipeline of precision medicine product candidates that target key muscle proteins and modulators to address a broad array of serious muscle disorders.

sevasemten is an allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address contraction-induced muscle injury currently being studied in multiple Phase 2 trials in Becker muscular dystrophy (Becker) and Duchenne muscular dystrophy (Duchenne), which are being held in the U.S., Israel, and certain countries in Europe and Australasia, and EDG-7500 is a novel, oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with hypertrophic cardiomyopathy (HCM) and other diseases of diastolic dysfunction currently being studied in a multipart Phase 2 trial for the potential treatment of obstructive and nonobstructive HCM.

The Company is also developing EDG-15400, currently in a Phase 1 trial of healthy adults with the future disease target of heart failure with preserved ejection fraction (HFpEF), and using its proprietary drug discovery platform to develop a pipeline of precision medicine product candidates that target key muscle proteins and modulators to address a broad array of serious muscle disorders.

Risks and Uncertainties

The board of directors of the Company discusses with management macroeconomic and geopolitical developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, the impact of the change in the U.S.

presidential administration, international conflicts, public health pandemics, cybersecurity and sanctions so that the Company can be prepared to react to new developments as they arise.

government administration and policy positions, international conflicts, public health pandemics, cybersecurity, sanctions, and changes in tariffs so that the Company can be prepared to react to new developments as they arise.

The board of directors and the management of the Company are carefully monitoring these developments and the resulting economic impact on its financial condition and results of operations.

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On June 16, 2023, the Company entered into a Sales Agreement (Sales Agreement) with BofA Securities, Inc.

(BofA Securities) under which the Company could offer and sell shares of common stock, having aggregate sales proceeds of up to $ 125,000,000 from time to time, through an “at the market offering” program (ATM Program) under which BofA Securities acted as sales agent.

(BofA Securities) under which the Company could offer and sell shares of common stock, having aggregate sales proceeds of up to $ 125.0 million from time to time, through an “at the market offering” program (ATM Program) under which BofA Securities acted as sales agent.

Effective January 19, 2024, the Company suspended and terminated the prospectus related to the Company’s common stock issuable pursuant to the terms of the Sales Agreement (the ATM Prospectus).

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The gross proceeds were $ 59.9 million, and the net proceeds were $ 59.4 million after deducting underwriting discounts and commissions of $ 0.2 million and offering expenses of $ 0.3 million.

On January 23, 2024, the Company closed an underwritten registered direct offering of 21,818,182 shares of common stock at a public offering price of $ 11.00 per share (the January 2024 Offering).

On January 23, 2024, the Company closed an underwritten registered direct offering of 21,818,182 shares of common stock at a public offering price of $ 11.00 per share (January 2024 Offering).

The aggregate gross proceeds from the January 2024 Offering were $ 240.0 million, and the net proceeds were $ 231.9 million after deducting underwriting discounts and commissions of $ 7.5 million and offering expenses of $ 0.6 million.

On May 10, 2024, we filed an automatic shelf registration statement on Form S-3ASR that allows us to undertake various equity and debt offerings.

Additionally, the Company filed a prospectus supplement to the shelf registration statement and entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) under which the Company may offer and sell shares of common stock, having aggregate sales proceeds of up to $ 175,000,000 from time to time, through an “at the market offering” program (Leerink ATM) under which Leerink Partners LLC will act as sales agent.

On May 10, 2024, the Company filed an automatic shelf registration statement on Form S-3ASR that allows the Company to undertake various equity and debt offerings.

Additionally, on May 10, 2024, the Company filed a prospectus supplement to the shelf registration statement and entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) under which the Company may offer and sell shares of common stock, having aggregate sales proceeds of up to $ 175.0 million from time to time, through an “at the market offering” program (Leerink ATM) under which Leerink Partners LLC will act as sales agent.

The Company has not yet offered or sold any shares of common stock related to the Leerink ATM.

On April 3, 2025, the Company closed an underwritten registered direct offering of 9,935,419 shares of common stock at a public offering price of $ 20.13 per share (April 2025 Offering).

The aggregate gross proceeds from the April 2025 Offering were $ 200.0 million, and the net proceeds were $ 187.1 million, after deducting underwriting discounts and commissions of $ 12.0 million and offering expenses of $ 0.9 million.

The Company’s ability to secure capital is dependent upon success in developing its technology and product candidates.

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Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and marketable securities.

Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits.

Periodically, the Company may maintain deposits in

financial institutions in excess of government insured limits.

The Company believes that it is not exposed to significant credit risk as its deposits are held at financial institutions that management believes to be of high credit quality.

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After consummation of the equity issuance, these costs are recorded as a reduction in the capitalized amount associated with the equity issuance.

Should the equity issuance be abandoned, the deferred offering costs are expensed immediately as a

charge to operating expenses in the statement of operations.

Deferred offering costs as of December 31, 2024 and December 31, 2023 were $ 0.3 million.

Should the equity issuance be abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the statement of operations.

Deferred offering costs were $ 0 as of December 31, 2025 and $ 0.3 million as of December 31, 2024.

Such costs are classified in other non-current assets in the accompanying balance sheets.

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government treasury and agency securities

Supranational and sovereign government securities

The Company’s money market funds are classified as Level 1 because they are valued using quoted market prices.

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government treasury and agency securities, and supranational and sovereign government securities have been classified as Level 2 as they are valued using quoted prices in less active markets or other directly or indirectly observable inputs.

Fair values of asset-backed securities, corporate debt securities, commercial paper, U.S.

government treasury and agency securities, and supranational and sovereign government securities were derived based on input of market prices from multiple sources at each reporting period.

Fair values of asset-backed securities, corporate debt securities, commercial paper, and U.S.

government treasury and agency securities were derived based on input of market prices from multiple sources at each reporting period.

With regard to commercial paper, all of the securities had high credit ratings and one year or less to maturity; therefore, fair value was derived from accretion of purchase price to face value over the term of maturity or quoted market prices for similar instruments if available.

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External costs consist primarily of payments to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), sample acquisition costs and laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, and process development and clinical development activities.

Internal costs consist primarily of

employee-related costs, facilities, depreciation and costs related to compliance with regulatory requirements.

Internal costs consist primarily of employee-related costs, facilities, depreciation and costs related to compliance with regulatory requirements.

Non-refundable advance payments for goods and services that will be used in future research and development activities are capitalized and recorded as an expense in the period that the Company receives the goods or when services are performed.

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Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued Accounting Standards Update (ASU) 2016-13, Financial Instruments - Credit Losses:

Measurement of Credit Losses on Financial Statements (Topic 326) (ASU 2016-13), which intends to improve financial reporting by requiring earlier recognition of credit losses on certain financial assets, such as available-for-sale debt securities.

Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance.

ASU 2016-13 was adopted on January 1, 2023 and the adoption of the new standard did not have a material impact on the Company's financial statements.

The Company monitors credit losses at each reporting period.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures to update reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance, in particular requiring public entities with a single reportable segment to provide all segment disclosures required by the update, as well as existing segment disclosures in Topic 280.

ASU 2023-07 was adopted for the Company’s annual report for the fiscal year ended December 31, 2024 and all quarterly and annual reports thereafter.

As the Company has a single reportable segment, the update resulted in additional footnote disclosure related identification of the Company’s chief operating decision maker and significant segment expenses (see Note 11).

Accounting Standards Not Yet Adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

In December 2023, the FASB issued Accounting Standards Update (ASU) 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures .

This ASU is expected to enhance the transparency and decision usefulness of income tax disclosures by requiring public business entities on an annual basis to disclose specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold, and certain information about income taxes paid.

This ASU is effective beginning with the Company’s 2025 fiscal year annual reporting period, with early adoption permitted.

The Company is currently evaluating the impact that the adoption of this standard will have on its financial statements.

This ASU enhanced the transparency and decision usefulness of income tax disclosures by requiring public business entities on an annual basis to disclose specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold, and certain information about income taxes paid.

ASU 2023-09 was adopted for the Company’s Annual Report for the fiscal year ended December 31, 2025 on a retrospective basis which resulted in enhanced income tax disclosures (see Note 6).

Accounting Standards Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expenses .

This ASU is expected to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization, and depletion) in commonly presented expense captions (such as cost of sales, SG&A, and research and development) This ASU is effective beginning with the Company’s 2027 fiscal year annual reporting period and interim periods thereafter, with early adoption permitted.

This ASU is effective beginning with the Company’s 2027 fiscal year annual reporting period and interim periods thereafter, with early adoption permitted.

The Company is currently evaluating the impact that the adoption of this standard will have on its financial statements.

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270):

Narrow Scope Improvements .

This ASU is expected to improve the navigability of the required interim disclosures and clarify when that guidance is applicable, and provide additional guidance on what disclosures should be provided in interim reporting periods, as well as add a principle that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity.

This ASU is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted.

The Company is currently evaluating the impact that the adoption of this standard will have on its interim financial statements.

NOTE 3 PREFERRED STOCK AND COMMON STOCK

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As of December 31, 2025 the total number of shares authorized was 1,200,000,000 .

The total number of shares of common

stock authorized was 1,000,000,000 .

The total number of shares of common stock authorized was 1,000,000,000 .

The total number of shares of preferred stock authorized was 200,000,000 .

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Equity Incentive Plans

In March 2021, the Company’s board of directors adopted, and its stockholders approved, the Company’s 2021 Equity Incentive Plan (the 2021 Plan), which became effective in March 2021 in connection with the IPO.

Upon adoption of the 2021 Plan, the Company restricted the grant of future equity awards under its 2017 Equity Incentive Plan, as amended and restated (the 2017 Plan).

The 2021 Plan provides for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any of its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, and performance shares to its employees, directors, and consultants and its subsidiary corporations’ employees and consultants.

In March 2021, the Company’s board of directors adopted, and its stockholders approved, the Company’s 2021 Equity Incentive Plan (2021 Plan), which became effective in March 2021 in connection with the IPO.

Upon adoption of the 2021 Plan, the Company restricted the grant of future equity awards under its 2017 Equity Incentive Plan, as amended and restated (2017 Plan).

The 2021 Plan provides for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any of its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock, restricted stock units (RSUs), stock appreciation rights, performance units, and performance shares to its employees, directors, and consultants and its subsidiary corporations’ employees and consultants.

The vesting of stock options is stated in each individual grant agreement, which is generally four years .

Options granted expire 10 years after the date of grant.

An RSU represents the right to receive one share of common stock upon vesting of the RSU.

The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant and generally vest over 2 to 4 years .

A total of 5,040,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the 2021 Plan.

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As of December 31, 2025, there were 2,599,220 shares available for future issuance under the 2021 Plan.

Inducement Equity Incentive Plan

Effective August 10, 2024, the Company’s board of directors adopted the Company’s 2024 Inducement Equity Incentive Plan (Inducement Plan) and, subject to the adjustment provisions of the Inducement Plan, reserved 2,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan.

The Inducement Plan was adopted without stockholder approval pursuant to the applicable The Nasdaq Stock Market LLC’s (Nasdaq) Listing Rules.

The Inducement Plan provides for the grant of equity-based awards, including nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, and performance awards, and its terms are substantially similar to the 2021 Plan, including with respect to treatment of equity awards in the event of a “merger” or “change in control” as defined under the Inducement Plan, but with such other terms and conditions intended to comply with the Nasdaq inducement award exception or to comply with the Nasdaq acquisition and merger exception.

In accordance with the Nasdaq Listing Rules, awards under the Inducement Plan may only be made to individuals not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company, or, to the extent permitted by the Nasdaq Listing Rules, in connection with a merger or acquisition.

vesting of stock options is stated in each individual grant agreement, which is generally four years , and expires 10 years after the date of grant.

The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant and vests over 4 years .

As of December 31, 2025, there were 1,009,750 shares available for future issuance under the Inducement Plan.

Stock Options

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Outstanding as of December 31, 2024

( 1,621,074 )

Outstanding as of December 31, 2025

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As of December 31, 2025, there was unrecognized stock-based compensation cost of $ 64.9 million, which is expected to be recognized over a weighted-average term of 2.8 years.

The aggregate intrinsic value of options exercised during the years ended December 31, 2024 and 2023 was $ 30.3 million and $ 1.0 million, respectively.

The aggregate intrinsic value of options exercised during the years ended December 31, 2025, 2024 and 2023 was $ 12.9 million, $ 30.3 million, and $ 1.0 million, respectively.

For options granted during the years ended December 31, 2025, 2024 and 2023, the weighted-average grant date fair value was $ 10.92 , $ 12.73 , and $ 5.25 per share, respectively.

The Company did not have any material awards modified during the years ended December 31, 2025, 2024 and 2023.

In previous years, there were additional options issued outside of this plan as discussed under Founder Stock Options.

Inducement Equity Incentive Plan

The Inducement Plan was adopted without stockholder approval pursuant to the applicable The Nasdaq Stock Market LLC’s (Nasdaq) Listing Rules.

As of December 31, 2024, there were 2,000,000 shares available for future issuance under the Inducement Plan.

Founder Stock Options

On September 19, 2017, the Company granted one of its founders the option to purchase 1,795,880 shares of the Company’s common stock at an exercise price of $ 0.18 per share which vest monthly over a four-year period that expires 15 years after the date of grant.

This grant is separate from the Company’s equity incentive plans discussed above.

As of December 31, 2024, 1,356,780 options were both outstanding and exercisable and there was no unrecognized stock-based compensation expense.

175,000 were options exercised during the year ended December 31, 2024 with an intrinsic value of $ 4.6 million.

As of December 31, 2024, the intrinsic value of options outstanding and exercisable was $ 36.0 million with a weighted-average remaining contractual life of 7.5 years.

Fair Value Assumptions

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78.67 % - 83.21 %

80.68 % - 85.68 %

Risk-free interest rate

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3.59 % - 4.66 %

3.47 % - 4.80 %

Expected dividend rate

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$ 16.33 - $ 33.57

$ 5.73 - $ 10.29

The expected term is based on the “simplified method” described in the U.S.

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The dividend yield was zero as the Company has never declared or paid dividends and has no plans to do so in the foreseeable future.

Founder Stock Options

On September 19, 2017, the Company granted one of its founders the option to purchase 1,795,880 shares of the Company’s common stock at an exercise price of $ 0.18 per share which vested monthly over a four-year period that expires 15 years after the date of grant.

This grant is separate from the Company’s equity incentive plans discussed above.

As of December 31, 2025, 1,147,365 options were both outstanding and exercisable and there was no unrecognized stock-based compensation expense.

During the years ended December 31, 2025 and 2024, 209,415 options with intrinsic value of $ 3.8 million and 175,000 options with intrinsic value of $ 4.6 million were exercised, respectively.

There were no options exercised during the year ended December 31, 2023.

As of December 31, 2025, the intrinsic value of options outstanding and exercisable was $ 28.3 million with a weighted-average remaining contractual life of 6.5 years.

Restricted Stock Units

A restricted stock unit (RSU) represents the right to receive one share of common stock upon vesting of the RSU.

The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant and vest over 3 or 4 years .

A RSU represents the right to receive one share of common stock upon vesting of the RSU.

The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant and generally vest over 3 or 4 years .

RSU activity for the year ended December 31, 2025 is as follows:

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As of December 31, 2025, there was unrecognized stock-based compensation cost of $ 15.5 million, which is expected to be recognized over a weighted-average term of 3.2 years.

The total fair value of RSUs vested during each of the years ended December 31, 2024 and 2023 was $ 0.7 million.

The total fair value of RSUs vested during the years ended December 31, 2025, 2024 and 2023 was $ 3.1 million, $ 0.7 million, and $ 0.7 million, respectively.

2021 Employee Stock Purchase Plan

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As of December 31, 2025, the Company has reserved for issuance 2,900,630 shares of common stock pursuant to the 2021 ESPP.

The 2021 ESPP provides for two offering periods of up to twelve months’ duration with purchase periods commencing on the first trading day on or after either May 15 and November 15, and terminating the last trading day on or before either May 15 or November 15 of the same year, and May 15 of the following year, respectively.

Contributions under the 2021 ESPP are limited to 15 % of an employee’s eligible compensation, IRS limitations, and a maximum of 6,000 shares during each offering period.

The 2021 ESPP provides for two offering periods of approximately twelve months’ duration, with purchase periods commencing on the first trading day on or after May 15 and November 15 and terminating on the last trading day on or before November 15 of the same year and May 15 of the following year, respectively.

Contributions under the 2021 ESPP are limited to 15 % of an employee’s eligible compensation, IRS limitations, and a maximum of 6,000 shares of common stock during each offering period.

2021 ESPP participants will purchase shares of common stock at a price per share equal to 85 % of the lesser of (1) the fair market value per share of the common stock on the first trading day of the offering period or (2) the fair market value of the common stock on the purchase date.

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Further, the Company provided a standby letter of credit (LOC) of $ 0.8 million during the term of the lease as collateral for the Company’s obligations under the lease.

Provided there has been no event of default by the Company during the initial 36-month term, the Company will replace the initial LOC with a replacement LOC in the amount of $ 0.5 million.

The New Boulder Lease includes two tenant improvement allowances, which includes one for $ 1.0 million in construction costs to be fully reimbursed by the lessor (the First Allowance) and one for $ 2.0 million in construction costs to be repaid to the lessor as additional rent payments over the initial term of the lease (the Second Allowance).

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The Expansion space includes an improvement allowance in the amount of $ 0.5 million to be fully reimbursed by the lessor.

As of December 31, 2024, $ 0.5 million was received by the lessor under the allowance associated with the expansion space.

The allowance associated with the expansion space has been received in full.

Under the New Boulder Lease and the Expansion Space (collectively, the Lease), the Company has the option to extend the Lease for two additional terms of five years each.

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Such amounts are not included in the measurement of the lease liabilities and are recognized as variable lease expense when they are incurred.

Variable lease expense was $ 0.5 million and $ 0.3 million for the years ended December 31, 2024 and 2023, respectively.

Variable lease expense was $ 0.4 million, $ 0.5 million, and $ 0.3 million for the years ended December 31, 2025, 2024 and 2023, respectively.

The Lease is classified as an operating lease.

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Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising of breach of such agreements or from intellectual property infringement claims made by third parties.

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising from breach of such agreements or from intellectual property infringement claims made by third parties.

In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors.

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Since inception, the Company has incurred net taxable losses, and accordingly, no current provision for income taxes has been recorded.

Net loss before income tax expense or benefit of $ 167.8 million, $ 133.8 million, and $ 100.2 million for the years ended December 31, 2025, 2024 and 2023, respectively, was incurred in the United States.

The Company has not recorded any United States federal or foreign income tax expense or benefit.

The effective income tax rate of the provision for income taxes differs from the federal statutory rate as follows:

As of December 31,

Federal tax at statutory rate

Research and development credits

State taxes, net of federal deduction

Disallowed compensation

Income tax benefit at federal statutory rate

State and local income taxes, net of federal income tax effect

Federal tax credits

Research and development

Change in valuation allowance

Non-deductible or non-taxable items

Section 162(m) limitations

Share based compensation

Effective income tax rate

Deferred tax assets and liabilities are as follows (in thousands):

The tax effect of temporary differences between the financial statement carrying amounts of existing assets and

liabilities and their respective tax bases that give rise to deferred tax assets and liabilities is as follows:

As of December 31,

Deferred tax assets (liabilities):

Capitalized research expenses

Deferred tax assets:

Federal net operating loss carryforward

Capitalized research expenses

Federal and state R&D credits

Orphan Drug Credit

State net operating loss carryforward

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Lease liability

Orphan Drug Credit

Property and equipment

Total net deferred tax asset

Total deferred tax assets before valuation allowance

Valuation allowance

Total deferred tax assets

Deferred tax liabilities:

Total deferred tax liabilities

Net deferred tax asset (liability)

For the period ended December 31, 2024, the Company has federal gross net operating loss (NOL) carryforwards of $ 146.3 million.

Of this amount, $ 1.2 million have a limited carryforward period and will begin to expire in 2037;

the remaining $ 145.1 million have an indefinite carryforward period.

The Company also has post-apportioned gross state NOL carryforwards of $ 155.6 million.

Of this amount, $ 122.9 million have a limited carryforward period and will begin to expire in 2037;

the remaining $ 32.7 million have an indefinite carryforward period.

The Company also has $ 16.6 million of federal research related tax credits carryforwards, which will begin to expire in 2039.

The Company also has

$ 0.9 million of state research related tax credits carryforward, of which $ 0.5 million will begin to expire in 2037;

For the period ended December 31, 2025, the Company has federal and state post-apportioned net operating loss (NOL) carryforwards of $ 319.7 million and $ 333.3 million, respectively.

Of the federal amount, $ 1.2 million have a limited carryforward period and will begin to expire in 2037;

the remaining $ 318.5 million will have an indefinite carryforward period.

Of the state post-apportioned amount, $ 300.6 million have a limited carryforward period and will begin to expire in 2037;

the remaining $ 32.7 million will have an indefinite carryforward period.

The Company also has federal and state tax credit carryforwards of $ 34.8 million and $ 3.1 million, respectively.

The full federal amount of $ 34.8 million has a limited carryforward period and will begin to expire in 2039.

Of the state tax credit carryforwards, $ 2.3 million will begin to expire in 2037;

the remaining $ 0.8 million have an indefinite carryforward period.

In accordance with Section 382 and Section 383, utilization of the NOL and tax credit carryforwards may subject to limitations based on prior or future ownership changes.

Also, after weighing all available and positive and negative evidence, the Company determined a full valuation allowance was necessary, consistent with prior year.

In accordance with Section 382 and Section 383, utilization of the NOL and tax credit carryforwards may be subject to limitations based on prior or future ownership changes.

After weighing all available positive and negative evidence, the Company determined a full valuation allowance was necessary, consistent with prior year.

The Company is subject to income tax in multiple jurisdictions, including federal and several states.

4 unchanged sentences

For the period ended December 31, 2025, the Company is not aware of any positions which require an uncertain tax position liability.

Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, the Company’s ability to use NOL and research tax credit carry forwards to offset future taxable income may be limited if the Company experiences a cumulative change in ownership of more than 50% within a three-year testing period.

The Company has not completed an ownership change analysis pursuant to IRC Section 382.

If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of NOL and research tax carryforwards available to offset future taxable income and income tax liabilities in future years may be significantly restricted or eliminated.

Further, deferred tax assets associated with such NOLs and research tax credits could be significantly reduced upon realization of an ownership change within the meaning of IRC Section 382.

NOTE 7 EMPLOYEE BENEFIT PLANS

1 unchanged sentence

The Company’s contribution to the plan, as determined by the Company’s Board of Directors, was discretionary until September 2021 when the Company initiated a match with a maximum amount of 4 % of the participant’s compensation.

During the years ended December 31, 2024 and 2023, the Company made matching contributions of $ 1.0 million and $ 0.6 million, respectively.

During the years ended December 31, 2025, 2024 and 2023, the Company made matching contributions of $ 1.2 million, $ 1.0 million, $ 0.6 million, respectively.

NOTE 8 NET LOSS PER SHARE

25 unchanged sentences

Property and equipment, net

Depreciation expense was $ 2.1 million and $ 1.6 million for the years ended December 31, 2024 and 2023, respectively.

Depreciation expense was $ 2.1 million, $ 2.1 million, and $ 1.6 million for years ended December 31, 2025, 2024 and 2023, respectively.

NOTE 10 ACCRUED OTHER EXPENSES

13 unchanged sentences

clinical and research data are key drivers in deciding how to allocate resources.

The CEO uses net loss and significant segment expenses to monitor budget versus actual results and make

decisions on whether to invest in internal or external resources to support the Company’s research and development programs, as well as determine if additional funding is needed for the Company’s research efforts.

The CEO uses net loss and significant segment expenses to monitor budget versus actual results and make decisions on whether to invest in internal or external resources to support the Company’s research and development programs, as well as determine if additional funding is needed for the Company’s research efforts.

Year Ended December 31,

10 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 8. Financial Statements and Supplementary Data